Ethics committees for clinical experimentation at international level with a focus on Italy

Ethics committees for clinical experimentation at international level with a focus on Italy

Authors

  • Zakira Naureen Department of Biological Sciences and Chemistry, College of Arts and Sciences, University of Nizwa, Nizwa, Oman
  • Tommaso Beccari Department of Pharmaceutical Sciences, University of Perugia, Perugia, Italy
  • Robert S. Marks Avram and Stella Goldstein-Goren Department of Biotechnology Engineering, Ben-Gurion University of the Negev, Beer-Sheva, Israel
  • Richard Brown Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Canada
  • Lorenzo Lorusso Neurology Unit, ASST-Lecco, Merate (LC), Italy
  • Derek Pheby Visiting Professor of Epidemiology (retired), Buckinghamshire New University, High Wycombe, UK
  • Stanislav Miertus Department of Biotechnology, University of SS. Cyril and Methodius, Trnava, Slovakia
  • Karen L. Herbst College of Medicine, University of Arizona, Tucson, Arizona, United States
  • Liborio Stuppia Department of Psychological, Health and Territorial Sciences, School of Medicine and Health Sciences, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy
  • Gary Henehan School of Food Science and Environmental Health, Technological University Dublin, Dublin 1, Ireland
  • Benedetto Falsini Institute of Ophthalmology, Fondazione Policlinico Gemelli IRCCS, Rome, Italy
  • Ludovica Lumer Department of Anatomy and Developmental Biology, Univerity College London, London, UK
  • Munis Dundar Department of Medical Genetics, Faculty of Medicine, Erciyes University, Kayseri, Turkey
  • Matteo Bertelli EBTNA-LAB, Rovereto (TN), Italy; MAGI EUREGIO, Bolzano, Italy; MAGI’S LAB, Rovereto (TN), Italy
  • International Bioethical Study Group International Bioethical Study Group

Keywords:

Ethics Committee, Italy, Clinical trials, Observational study, risks, Food related research, ethics

Abstract

Guiding legislation and associated bureaucracy for the ethical review of clinical trials observational studies and food related research play an important role in the competitiveness of a nation in the face of tough global competition to attract sponsors and investigators. This is of particular relevance in the case of multicentre trials and multidisciplinary research. Accordingly, in this report we tried to gather in-depth knowledge of the current role and practices of ethics committees nationwide in both clinical and research settings. This mini-review aims to describe the formulation and organization of ethical committees in Italy in order to provide a focus for deliberations on ethical issues in medical and scientific research in line with human rights, as set out in the European Union charter. Furthermore, we evaluated the impact of an institution’s ethical committee intervention on reducing the time required to obtain an opinion from Research Ethics Committees by guiding investigators in addressing ethical issues in their proposed studies.

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Published

09-11-2020

How to Cite

1.
Naureen Z, Beccari T, Marks RS, Brown R, Lorusso L, Pheby D, et al. Ethics committees for clinical experimentation at international level with a focus on Italy. Acta Biomed [Internet]. 2020 Nov. 9 [cited 2024 Oct. 11];91(13-S):e2020016. Available from: https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/10643